Kornimate/medical-research-clean huggingface dataset:
evaluation of miseq for microbial identification in specimens

Conditions: Blood Stream Infections

Summary: background: researchers are testing a new way to find out what causes infections in people in hospitals. current techniques use chemical or biological tests on a person s samples. samples are blood, tissue, stool, saliva, urine, etc. researchers are testing new techniques that use a device called miseq. it can sequence all of the dna (genetic material) in a sample. this may show microorganisms, such as bacteria, fungi, and viruses that cause infection. researchers want to know if the new test works as well or better than current tests. they will do this by looking at about 250 samples. objective: to test if miseq works as well as or better than current tests to identify microorganisms that cause infection. eligibility: nih patients whose samples have been sent to the microbiology service s lab for routine microbiologic testing. design: participants will consent to have samples they gave as part of their routine medical care used in the study. for those under age 18, a parent or legal guardian will consent.

the purpose of this study is to evaluate and optimize testing that uses a next-generation dna sequencing instrument, illumina miseq, along with the associated computer infrastructure and bioinformatics software required for sequence analysis. this system is ultimately intended for use by the nih clinical center department of laboratory medicine to identify infectious agents in primary patient specimens. next generation sequencing techniques based on sequencing of total dna from primary specimens are expected to have many advantages over classical microbiological approaches. these include the detection of pathogens directly from primary specimens that may be difficult or impossible to culture. in this study, discarded patient samples and autopsy material will be tested with the miseq system to identify and classify bacteria, viruses, and other pathogens. for the purpose of this study, the term samples will refer to any sample such as swabs, tissue biopsies, blood, feces, saliva, urine, wound, etc. the investigators analyzing the sequencing results will be blinded to the microbiology culture results for a validation subset of specimens to be tested with the miseq system. the results of the miseq analysis will be converted into a form that can be compared with the microbiology services official culture results that are stored in the laboratory information system (software from scc soft computer \[clearwater, fl, usa\]).

Eligibility criteria:
* inclusion criteria 1. discarded specimens will be used for this study. 2. patients from whom the specimens are derived are required to be consented.

Keywords: sequence technique infectious disease pathogen detection diagnostic natural history
virtual reality for anxiety relief in infertile women

Conditions: Anxiety; Assisted Reproductive Treatments; Women; VR; Stress; Virtual Goggles; Infertility; Embryo Transfer

Summary: this study examines the impact of virtual reality (vr) applications on anxiety levels before and after embryo transfer procedures. the clinical trial will involve 80 participants, aged 18 to 50, who are receiving treatment at a healthcare facility in the turkish republic of northern cyprus (trnc). the primary objective is to evaluate the effectiveness of vr as an intervention for reducing anxiety in individuals undergoing assisted reproductive treatments.

this doctoral study aims to evaluate the use of virtual reality (vr) as an innovative, non-invasive intervention for managing anxiety during embryo transfer in assisted reproductive technology (art). a randomized clinical trial will be conducted with 80 participants, aged 18 to 50, undergoing fertility treatment at a healthcare facility in the turkish republic of northern cyprus (trnc). participants will be randomly assigned to one of two groups: the intervention group (n=40), which will experience a vr session both before and after the embryo transfer, and the control group (n=40), which will receive standard care without vr. anxiety levels will be assessed using the state-trait anxiety inventory (stai) at two time points-pre- and post-embryo transfer. the primary objective of this study is to determine the effectiveness of vr in reducing procedural anxiety, a factor known to negatively affect patient experience and potentially influence treatment outcomes. the findings are expected to support the integration of patient-centered, technology-enhanced strategies in reproductive healthcare practices.

Eligibility criteria:
inclusion criteria: * volunteered to participate in the research, * 18-50 years old * no vision and hearing problems, * not disoriented in time and place, * primary infertile * not having communication problem * can read \& write * no mental pathological disease exclusion criteria: * secondary infertility * having experienced bleeding, miscarriage, etc. after embryo transfer, * difficulty communicating, * problems such as migraine, vertigo, dizziness, * patients who wear prescription glasses and have vision problems without glasses * refused to participate in the research * patients with psychiatric pathology

Keywords: anxiety assisted reproductive treatments women nurse vr technology infertility embryo transfer
safety and efficacy of the toothwave -12 weeks calculus study

Conditions: Gingivitis; Plaque; Calculus, Dental

Summary: the objective of the study is to evaluate the safety and efficacy of the home-use device silk'n toothbrush (toothwave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.

this is a single blind, prospective study aimed to evaluate the safety and efficacy of the silk'n toothbrush in reduction of gingivitis, dental plaque and calculus. the study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks. one treatment group (silk'n toothbrush - toothwave) and 1 control group (an ada approved power toothbrush (ptb)) will participate in the study. for each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. calculus condition will be measured after 12 weeks in addition to the other timepoints. the average data sets will be calculated for each group. treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). brushing will be undertaken using the silk'n toothbrush and standard fluoride toothpaste. the control group will use a regular ptb and standard fluoride toothpaste.

Eligibility criteria:
inclusion criteria 1. adult subjects aged 18-70, that are in good health. 2. subject must have: 2.1. baseline gingivitis (mgi) score of at least 1.80. 2.2. baseline gingival bleeding (gbi) of ≥1 on at least 20 sites. 2.3. dental plaque mean score greater than 0.6 according to the rmnpi (rustogi modified navy plaque index). 2.4. total calculus deposits greater than 9 according to the volpe-manhold index. 3. have a minimum of 20 'scorable' teeth (excluding 3rd molars). 4. the subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. subjects will sign the informed consent form. 5. the subjects should be willing to comply with the study procedure and schedule, including the follow up visits. exclusion criteria 1. current or history of oral cavity cancer or oropharyngeal cancer. 2. pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. 3. pregnant or nursing by subject report. 4. any active condition in the oral cavity at the discretion of the investigator. 5. any surgery in the oral cavity within 3 months prior to treatment, or before complete healing. 6. subjects that do not brush regularly. 7. any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
quality of life and sexual life in hemodialysis patients: effects of an intradialytic exercise program

Conditions: Chronic Kidney Diseases; Sexual Dysfunction

Summary: the aim of the study is to investigate whether an intradialytic exercise program can improve the quality of life, sexual function, and sexual satisfaction in patients undergoing hemodialysis.

when diagnosed with chronic kidney disease phase 5, patients are dialyzed to remove waste products and toxins from the blood that kidneys can´t longer filter. although hemodialysis removes most of the toxins and allows health improvement, patients continue reporting a low quality of life and limitations in their functional independence. within the context of quality of life, sexuality is an important factor; a high incidence of sexual dysfunctions has been reported among hemodialysis patients. although poorly addressed, it impacts family and couple relationships, emotions, and mental health. exercise interventions improve physical function and quality of life, and since some of the mechanisms involved in exercise are also involved in sexual activity, an exercise intervention could be an effective approach to sexual dysfunctions without the risk and stigma of sexual or drug therapy. therefore the study aims to implement an intradialytic exercise program involving aerobic, resistance, and kegel exercises (specific to the pelvic floor) and determine its effects on quality of life, sexual function, and sexual satisfaction in patients undergoing hemodialysis.

Eligibility criteria:
inclusion criteria: * participants with stage 5 of chronic kidney disease * participants that are undergoing hemodialysis for at least 3 months * participants between 18 and 70 years old * their participation is voluntary and they have signed the informed consent form * participants that have medical approval from their nephrologist exclusion criteria: * participants with severe cardiovascular damage (nyha \>3) * participants with a high probability of receiving a transplant within 6 months * participants with psychiatric or psychological disorders such as severe depression (beck index) that can affect their ability to consent or participate in the study * participants that perform physical exercise at least 2 times a week for the last 3 months or more * participants with bilateral lower limb amputation * participants with vascular access located in lower limbs * pregnant participants

Keywords: intradialytic exercise hemodialysis sexual dysfunctions kidney disease
the comparison of efficacy and safety of the mesenchymal stem cells from adipose and hyaluronic acid

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to evaluate the efficacy and safety of mesenchymal stem cells (mscs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(oa).

this is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.participants in experiment group will receive the treatment of mscs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. unexplained local and systemic symptoms as well as visual analog scale pain score, westernontario mcmasteruniversities (womac) osteoarthritis index scorewill be assessed at baseline and 2 years after the injection.

Eligibility criteria:
inclusion criteria: * k / l score of 2-3; * chronic knee pain; * no local or systemic infection; * without obvious contraindication of the joint puncture from hematology and biochemical tests; * informed consent. exclusion criteria: * older than 75 years old or less than 18 years old, or without full capacity for civil conduct; * hiv, hepatitis virus or syphilis virus infection or their serology is positive; * bmi index is greater than 30; * congenital or acquired knee deformity; * pregnant or lactating women; * tumor patients; * immunodeficiency patients; * intra-articular drug injection history within 3 months; * participating in other clinical trials; * other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.

Keywords: knee osteoarthritis adipose mesenchymal stem cells
surgical treatment of ischemic mitral regurgitation

Conditions: Mitral Valve Insufficiency

Summary: the primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with cabg in patients with cad and impact on heart failure and progress of mitral regurgitation.


Eligibility criteria:
inclusion criteria: * patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent. * patients with a verified diagnosis of cad, including post myocardial infarction scar. * coronary artery pathology to be coronary artery bypasses grafting. * the presence of moderate or severe ischemic mitral regurgitation. exclusion criteria: * the patient did not sign the informed consent. * aortic valve disease requiring prosthetic or aortic valve repair. * organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve). а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve * patients with acute coronary syndrome. * the presence of the indications for angioplasty of the coronary arteries. * coronary artery bypasses grafting in history. * parallel patient participation in other studies. * the organs diseases, which can be reason to death after surgery during the first 3 years.

Keywords: ischemic mitral valve insufficiency svr
usefulness and predictive capacity of ani and spi of the hemodynamic response

Conditions: Pain; Tachycardia; Hypertension

Summary: the primary objective of this study is to investigate the influence of a standardized noxious stimulus on the ani, spi and hemodynamic parameters during standard propofol and sufentanil tci and to see if the ani and spi are predictive of a hemodynamic reaction. in addition the investigators compare the performance of ani and spi against one another as well as investigate if ani or spi can be used to find the ideal cesuf for a given patient.

during general anesthesia hypnosis can be monitored routinely using eeg derivates like bispectral index (bis), entropy,.... however, monitoring analgesia or more precisely the nociceptive-antinociceptive (analgetic) balance during anesthesia proved more difficult. clinical signs such as heart rate (tachycardia) or blood pressure (hypertension) are usually observed and used to assess nociception and a patient's autonomic unbalance. during general anesthesia administration of opioids like sufentanil and remifentanil decrease the ans reactivity to noxious stimulation. recently two variables based on standard anesthesia monitor equipment have been introduced into clinical practice: the analgesia nociception index (ani), derived from analysis of the small beat-to-beat oscillations of the heart rate during respiration, the heart rate variability (hrv), and the surgical pleth index (spi), calculated from the plethysmographic amplitude and heart beat interval.

Eligibility criteria:
inclusion criteria: * male * non-pregnant female participants * asa ii-iii * \>18-65 years * weight not exceeding 30% under or above ideal body weight * elective intracranial surgery or circumcision. exclusion criteria: * use concurrent opioid containing drugs * use of any autonomic nervous system altering drugs * history of opioid or alcohol abuse * hepatic, renal, metabolic, neuromuscular or cardiovascular disease * known allergies to anesthestetic / analgesic drugs * use of a peripheral nerve block, penile block

Keywords: ani spi autonomic balance nociception measurement
pharmacokinetics of antiretroviral drugs in lactating women and breastmilk fed infants under 6 months of age in botswana

Conditions: Lactating Women on Select DOI; Breastmilk Fed Infants of Mothers on Select DOI; HIV Infections

Summary: the purpose of this study is to characterize the pharmacokinetics (pk) of understudied drugs administered to lactating women, receiving antiretroviral drugs per soc as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.

prospective, single-site, open label, pk and safety study. co-enrollment of lactating women ≥18 years of age receiving drugs of interest (dois) per standard of care (soc), as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ≤180 days postpartum. to understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). the opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per soc to maximize study efficiency and data collection and minimize potential risk to participants. the data collected through this initiative will provide valuable pk, dosing, and safety information for drugs in this vulnerable population in order to inform public health.

Eligibility criteria:
inclusion criteria mothers/infants: 1. lactating women ≥18 years of age who are receiving at least one doi per soc who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk. 2. informed consent, according to local irb/reb/iec guidelines, prior to any study-related procedures. 3. if the mother is receiving more than one doi, the mother must have taken all dois that she is receiving concomitantly for the 6 doses prior to sample collection. 4. mother participant is fluent in english or setswana. 5. willing to provide at least 1 of the below required samples between the co-enrolled mother/infant pair: * maternal breastmilk * infant blood exclusion criteria mothers/infants: 1. any concomitant condition which, in the opinion of the participant's healthcare provider, the site principal investigator (pi), a research nurse, or designee conducting the study, would preclude participation in the study. 2. known pregnancy of mother during sample collection. 3. mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection. 4. infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection. 5. previous enrollment on this study.
real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage iii nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.

study design: prospective multi-center non-interventional cohort study data source(s): medical records of patients who are treated with durvalumab following chemoradiation therapy study population: patients prescribed and treated with durvalumab for unresectable stage iii non-small cell lung cancer (nsclc) at first time following chemoradiation therapy and who provide written informed consent. exposure(s): durvalumab outcome(s): summary of pneumonitis and adverse event special interest (aesi), progression free survaival (pfs), overall survaival (os), reasons of discontinuation of durvalumab treatment, details of subsequent treatments after durvalumab sample size estimations: 500 patients statistical analysis: only descriptive analysis and no formal test

Eligibility criteria:
inclusion criteria: * patients who receive durvalumab for unresectable stage iii nsclc at first time following chemoradiation therapy. * patients who provided written informed consent. exclusion criteria: * patients who would join post marketing surveyllance for durvalumab. * patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment * age \< 20

Keywords: nsclc, stageiii, durvalumab, japanese, real world
effects of dehydroepiandrosterone (dhea) in humans

Conditions: Aging

Summary: the purpose of this study is to determine whether bringing back the dhea levels of older persons to the young range produces beneficial effects.

dhea and dhea sulfate (dheas) plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr. dhea is a ppar-alpha activator. ppar-alpha plays major roles in regulating lipid metabolism and controlling inflammation. dhea also appears to have anabolic effects on muscle and bone. the study is designed to determine the effects of 12 months of dhea replacement in 65-75 year old women and men on (a) truncal and visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength, (d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent vasodilation, and (g) sense of well being. the specific aims of this study are to test the hypotheses that 12 months of dhea replacement will (a) result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage; (b) decrease insulin resistance and decrease serum triglycerides; (c) increase muscle mass and strength, by decreasing catabolic stimuli and increasing anabolic stimuli; (d) increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli; (e) reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells; (f) improve arterial endothelium dependent vasodilation; and (g) improve general sense of well being.

Eligibility criteria:
inclusion criteria: * 65 to 75 years old * physically healthy * non-smoker * on stable medications for at least 6 months * stable body weight for the past year exclusion criteria: * serious active medical problems * hormone therapy * abnormal psa (prostate specific antigen) in men

Keywords: metabolic syndrome
polypharmacy and clinically significant drug interactions among hiv-infected patients receiving antiretroviral therapy

Conditions: HIV

Summary: this will be a cross-sectional population-based study carried out in the region of madrid (6,468,322 inhabitants according to current census) to quantify the number of co-meds in hiv-infected individuals on art in the region of madrid, categorized by age and gender, and to compare the number of co-meds between the art-treated population and hiv-uninfected population in the region of madrid, categorized by age and gender.

this will be a cross-sectional population-based study carried out in the region of madrid (6,468,322 inhabitants according to current census) to quantify the number of co-meds in hiv-infected individuals on art in the region of madrid, categorized by age and gender, and to compare the number of co-meds between the art-treated population and hiv-uninfected population in the region of madrid, categorized by age and gender.

Eligibility criteria:
inclusion criteria: * patients who picked-up co-meds in the study period exclusion criteria: * none